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Short-course therapy of acute bacterial exacerbation of chronic bronchitis: a double-blind, randomized, multicenter comparison of extended-release versus immediate-release clarithromycin.
Curr Med Res Opin. 2003; 19(5):411-20.CM

Abstract

OBJECTIVE

The objective of this study was to compare the efficacy and safety of two clarithromycin formulations given for 5 days to patients with acute bacterial exacerbation of chronic bronchitis (ABECB).

PATIENTS AND METHODS

This was a double-blind, randomized, multicenter study of ambulatory patients between 40 and 75 years of age with a medical history of chronic bronchitis, chronic obstructive pulmonary disease and a presumptive diagnosis of ABECB who met Anthonisen Type 1 criteria (increased dyspnea, increased sputum volume and increased sputum purulence). Eligible patients received a 5-day course of clarithromycin extended-release (ER) 500 mg once daily or clarithromycin immediate-release (IR) 250 mg twice daily. Clinical cure, bacteriological cure and pathogen eradication rates were determined at the end of therapy and at a follow-up visit.

RESULTS

Clinical cure rates were similar at the test-of-cure visit for evaluable patients in the clarithromycin ER group (97%, 298/307) and clarithromycin IR group (98%, 300/307) (95% CI (-3.2, 1.9)). The bacteriological cure rate was 89% and the pathogen eradication rate was 90% in both treatment groups. Resolution or improvement in cough, sputum production, sputum volume and sputum appearance was observed in > 90% of evaluable patients in each treatment group. The incidence of study drug-related adverse events was 6.6% (23/351) in the clarithromycin ER group and 5.4% (19/352) in the clarithromycin IR group. The most frequently occurring study drug-related adverse events were abdominal pain, diarrhea and taste perversion.

CONCLUSION

Clarithromycin ER 500 mg once daily for 5 days is equivalent to clarithromycin IR 250 mg twice daily for 5 days in treating adults with ABECB. Both regimens were effective in resolving clinical signs and symptoms of ABECB and eradicating the target pathogens, and were well tolerated.

Authors+Show Affiliations

Krakow, Poland.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

13678478

Citation

Nalepa, Piotr, et al. "Short-course Therapy of Acute Bacterial Exacerbation of Chronic Bronchitis: a Double-blind, Randomized, Multicenter Comparison of Extended-release Versus Immediate-release Clarithromycin." Current Medical Research and Opinion, vol. 19, no. 5, 2003, pp. 411-20.
Nalepa P, Dobryniewska M, Busman T, et al. Short-course therapy of acute bacterial exacerbation of chronic bronchitis: a double-blind, randomized, multicenter comparison of extended-release versus immediate-release clarithromycin. Curr Med Res Opin. 2003;19(5):411-20.
Nalepa, P., Dobryniewska, M., Busman, T., & Notario, G. (2003). Short-course therapy of acute bacterial exacerbation of chronic bronchitis: a double-blind, randomized, multicenter comparison of extended-release versus immediate-release clarithromycin. Current Medical Research and Opinion, 19(5), 411-20.
Nalepa P, et al. Short-course Therapy of Acute Bacterial Exacerbation of Chronic Bronchitis: a Double-blind, Randomized, Multicenter Comparison of Extended-release Versus Immediate-release Clarithromycin. Curr Med Res Opin. 2003;19(5):411-20. PubMed PMID: 13678478.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Short-course therapy of acute bacterial exacerbation of chronic bronchitis: a double-blind, randomized, multicenter comparison of extended-release versus immediate-release clarithromycin. AU - Nalepa,Piotr, AU - Dobryniewska,Malgorzata, AU - Busman,Todd, AU - Notario,Gerard, PY - 2003/9/19/pubmed PY - 2004/3/25/medline PY - 2003/9/19/entrez SP - 411 EP - 20 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 19 IS - 5 N2 - OBJECTIVE: The objective of this study was to compare the efficacy and safety of two clarithromycin formulations given for 5 days to patients with acute bacterial exacerbation of chronic bronchitis (ABECB). PATIENTS AND METHODS: This was a double-blind, randomized, multicenter study of ambulatory patients between 40 and 75 years of age with a medical history of chronic bronchitis, chronic obstructive pulmonary disease and a presumptive diagnosis of ABECB who met Anthonisen Type 1 criteria (increased dyspnea, increased sputum volume and increased sputum purulence). Eligible patients received a 5-day course of clarithromycin extended-release (ER) 500 mg once daily or clarithromycin immediate-release (IR) 250 mg twice daily. Clinical cure, bacteriological cure and pathogen eradication rates were determined at the end of therapy and at a follow-up visit. RESULTS: Clinical cure rates were similar at the test-of-cure visit for evaluable patients in the clarithromycin ER group (97%, 298/307) and clarithromycin IR group (98%, 300/307) (95% CI (-3.2, 1.9)). The bacteriological cure rate was 89% and the pathogen eradication rate was 90% in both treatment groups. Resolution or improvement in cough, sputum production, sputum volume and sputum appearance was observed in > 90% of evaluable patients in each treatment group. The incidence of study drug-related adverse events was 6.6% (23/351) in the clarithromycin ER group and 5.4% (19/352) in the clarithromycin IR group. The most frequently occurring study drug-related adverse events were abdominal pain, diarrhea and taste perversion. CONCLUSION: Clarithromycin ER 500 mg once daily for 5 days is equivalent to clarithromycin IR 250 mg twice daily for 5 days in treating adults with ABECB. Both regimens were effective in resolving clinical signs and symptoms of ABECB and eradicating the target pathogens, and were well tolerated. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/13678478/Short_course_therapy_of_acute_bacterial_exacerbation_of_chronic_bronchitis:_a_double_blind_randomized_multicenter_comparison_of_extended_release_versus_immediate_release_clarithromycin_ L2 - https://www.tandfonline.com/doi/full/10.1185/030079903125002018 DB - PRIME DP - Unbound Medicine ER -